NavLock Tracker *** Rx Only
FDA device recall Z-1693-2020 · posted 2020-04-10 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Product was incorrectly assembled which could affect navigation accuracy of the device.
- Action taken
- On 08/28/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to its customer informing them of the manufacturing issue (incorrect assembly) and instructed them to: 1. Examine their inventory, and immediately quarantine the affected NavLock" Tracker and to return to the Recalling Firm. 2. To contact the Recalling Firm at 1-888-826-5603 to receive a return material authorization (RMA) and to arrange for return and a no-charge replacement. Once an RMA number is obtained, ship the affected product to Medtronic Product Services, 1480 Arthur Ave, Louisville CO 80027. 3. Follow instructions on the attached Customer Confirmation Form. Sign and date the bottom of the form and then return the form to RS.NavFCA@medtronic.com or fax it to Medtronic at 651-367-7075.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 1 unit
- Distribution
- U.S.: NY No O.U.S.
- Date initiated
- 2019-08-28
- Date posted
- 2020-04-10
- Date terminated
- 2021-05-05
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NavLock Trackers, Robotic Reference Frame (K182104) | Medtronic Navigation | 2018-11-02 |
| NavLock Trackers (K171267) | Medtronic Navigation | 2017-07-03 |